Mesoblast lifts off on stem cell go-ahead

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Adult stem cell specialist Mesoblast can start testing its
technology in humans, after receiving ethics approval for its first
orthopaedic study.

News of the pilot study, to be carried out at the Royal
Melbourne Hospital, sent the biotech's shares 7¢ higher to
58¢. At one stage the share price jumped more than 20 per
cent.

The independent trial will involve up to 10 patients with long
bone fractures that have failed to heal properly and will primarily
test the safety of the stem cell therapy. Results could be
available by July.

Pre-clinical animal studies have already shown that Mesoblast's
technology is safe and able to generate new bone growth, but this
trial will be the first time that it is tested in humans.

Stephen Graves, who will act as principal investigator
throughout the trial, said that between 5 and 10 per cent of tibial
fractures were associated with healing difficulties.

"Significant problems often occur in this field that lead to
substantial pain, loss of mobility, and therefore reduced quality
of life for many patients," Professor Graves said. "Patients
enrolled in the trial have limited options available to them and
have likely been through several previous procedures."

The trial, which will start as soon as the first patient is
recruited, will involve extracting the subject's own stem cells,
harvesting and expanding them at the Peter MacCallum Cancer
Institute's cell therapies division, and then implanting them back
into the affected area of the body.

This process should take about eight weeks.

Patients will be monitored throughout the trial for any adverse
effects. And while the primary aim of the study is to ascertain
that the treatment is safe, investigators will also look for signs
of bone regeneration as an early indicator of efficacy.

Mesoblast executive chairman Michael Spooner said existing
treatments for orthopaedic conditions were a significant cost to
the Australian and international health-care systems.

"Importantly, this trial is intended to target only one of a
number of substantial, unmet, orthopaedic illnesses and diseases,
which Mesoblast intends to address," Mr Spooner said.

The company is also undertaking a pre-clinical trial at Colorado
State University in the United States, to support an
"investigational new drug" submission to the Food and Drug
Administration.

And it has approval for a trial involving patients with severe
coronary artery disease at John Hunter Hospital in Newcastle.

Mr Spooner would not comment on the expected cost of the trial
but said the company's cash reserve of about $15 million would
cover both pilot studies.

Mesoblast said that it expected to give the market regular
updates on progress made in the study.